Recommendations from the European Commission Initiative on Breast Cancer for multigene testing to guide the use of adjuvant chemotherapy in patients with early breast cancer, hormone receptor positive, HER-2 negative
Giorgi Rossi, Paolo (Azienda USL-IRCCS di Reggio Emilia)
Lebeau, Annette (University Medical Center Hamburg-Eppendorf)
Canelo Aybar, Carlos Gilberto (Institut d'Investigació Biomèdica Sant Pau)
Saz-Parkinson, Zuleika (Instituto de Salud Carlos III)
Quinn, Cecily (St Vincent's Hospital (Sydney))
Langendam, Miranda W (Amsterdam UMC. University Medical Center)
Mcgarrigle, Helen (Cardiff and Vale UHB - General Surgery, Cardiff, UK)
Warman, Sue (Havyatt Lodge, Havyatt Road, Langford, North Somerset UK)
Rigau, David (Institut d'Investigació Biomèdica Sant Pau)
Alonso-Coello, Pablo (Institut d'Investigació Biomèdica Sant Pau)
Broeders, Mireille (Dutch Expert Centre for Screening)
Graewingholt, Axel (Radiologie am Theater, Paderborn, NRW Germany)
Posso, Margarita (Institut Hospital del Mar d'Investigacions Mèdiques)
Duffy, Stephen W (Queen Mary University of London. Centre for Cancer Prevention)
Schünemann, Holger (McMaster University Health Sciences Centre, Hamilton. Michael G. DeGroote Cochrane Canada and McGRADE Centres; Department of Health Research Methods, Evidence and Impact)
Universitat Autònoma de Barcelona

Data:	2021
Resum:	Predicting the risk of recurrence and response to chemotherapy in women with early breast cancer is crucial to optimise adjuvant treatment. Despite the common practice of using multigene tests to predict recurrence, existing recommendations are inconsistent. Our aim was to formulate healthcare recommendations for the question "Should multigene tests be used in women who have early invasive breast cancer, hormone receptor-positive, HER2-negative, to guide the use of adjuvant chemotherapy?" The European Commission Initiative on Breast Cancer (ECIBC) Guidelines Development Group (GDG), a multidisciplinary guideline panel including experts and three patients, developed recommendations informed by systematic reviews of the evidence. Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision frameworks were used. Four multigene tests were evaluated: the 21-gene recurrence score (21-RS), the 70-gene signature (70-GS), the PAM50 risk of recurrence score (PAM50-RORS), and the 12-gene molecular score (12-MS). Five studies (2 marker-based design RCTs, two treatment interaction design RCTs and 1 pooled individual data analysis from observational studies) were included; no eligible studies on PAM50-RORS or 12-MS were identified and the GDG did not formulate recommendations for these tests. The ECIBC GDG suggests the use of the 21-RS for lymph node-negative women (conditional recommendation, very low certainty of evidence), recognising that benefits are probably larger in women at high risk of recurrence based on clinical characteristics. The ECIBC GDG suggests the use of the 70-GS for women at high clinical risk (conditional recommendation, low certainty of evidence), and recommends not using 70-GS in women at low clinical risk (strong recommendation, low certainty of evidence).
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Prognostic markers ; Breast cancer
Publicat a:	British journal of cancer, Vol. 124 (february 2021) , p. 1503-1512, ISSN 1532-1827

DOI: 10.1038/s41416-020-01247-z
PMID: 33597715

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